The PRO-RCC study: a long-term PROspective Renal Cell Carcinoma cohort in the Netherlands, providing an infrastructure for ‘Trial within Cohorts’ study designs

Hilin Yildirim*, Christiaan V. Widdershoven, Maureen Jb Aarts, Axel Bex, Haiko J. Bloemendal, Deirdre M. Bochove-Overgaauw, Paul Hamberg, Karin H. Herbschleb, Tom van der Hulle, Brunolf W. Lagerveld, Martijn Gh van Oijen, Sjoukje F. Oosting, Johannes V. van Thienen, Astrid Am van der Veldt, Hans M. Westgeest, Evelijn E. Zeijdner, Katja Kh Aben, Corina van den Hurk, Patricia J. Zondervan, Adriaan D. Bins

*Corresponding author for this work

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Background: Ongoing research in the field of both localized, locally advanced and metastatic renal cell carcinoma has resulted in the availability of multiple treatment options. Hence, many questions are still unanswered and await further research. A nationwide collaborative registry allows to collect corresponding data. For this purpose, the Dutch PROspective Renal Cell Carcinoma cohort (PRO-RCC) has been founded, for the prospective collection of long-term clinical data, patient reported outcome measures (PROMs) and patient reported experience measures (PREMs). Methods: PRO-RCC is designed as a multicenter cohort for all Dutch patients with renal cell carcinoma (RCC). Recruitment will start in the Netherlands in 2023. Importantly, participants may also consent to participation in a ‘Trial within cohorts’ studies (TwiCs). The TwiCs design provides a method to perform (randomized) interventional studies within the registry. The clinical data collection is embedded in the Netherlands Cancer Registry (NCR). Next to the standardly available data on RCC, additional clinical data will be collected. PROMS entail Health-Related Quality of Life (HRQoL), symptom monitoring with optional ecological momentary assessment (EMA) of pain and fatigue, and optional return to work- and/or nutrition questionnaires. PREMS entail satisfaction with care. Both PROMS and PREMS are collected through the PROFILES registry and are accessible for the patient and the treating physician. Trial registration: Ethical board approval has been obtained (2021_218) and the study has been registered at (NCT05326620). Discussion: PRO-RCC is a nationwide long-term cohort for the collection of real-world clinical data, PROMS and PREMS. By facilitating an infrastructure for the collection of prospective data on RCC, PRO-RCC will contribute to observational research in a real-world study population and prove effectiveness in daily clinical practice. The infrastructure of this cohort also enables that interventional studies can be conducted with the TwiCs design, without the disadvantages of classic RCTs such as slow patient accrual and risk of dropping out after randomization.

Original languageEnglish
Article number648
JournalBMC Cancer
Issue number1
Publication statusPublished - 11 Jul 2023

Bibliographical note

Funding Information:
We would like to thank the Profiles Registry advisory board , the Dutch Federation of Cancer Patient Organizations (NFK), the Dutch patient association of bladder or kidney cancer (”Leven met Blaas- of Nierkanker”) for their contribution in the design of the cohort. We would like to thank the following experts on their contribution in the design of the cohort: Nutrition: Dr. A. Vrieling, Dr. S. Beijer. EMA: dr. B. de Rooij en prof. M. van der Lee for the EMA expertise. Cost-effectiveness: Dr. S. de Groot. Return to work: Prof. A. de Boer, Dr. S. Duijts.

To date, PRO-RCC received funding for the set-up and maintenance of the
infrastructure from MSD, Ipsen and Bristol Myers Squibb. The funding parties
did not contribute to the study design or the manuscript.
Award/grant number: N/A.

Publisher Copyright:
© 2023, The Author(s).


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